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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K240543
Device Name Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
Applicant
Medency S.R.L.
Via Degli Ontani, 48
Vicenza,  IT 36100
Applicant Contact Alessandro Zorgati
Correspondent
Medency S.R.L.
Via Degli Ontani, 48
Vicenza,  IT 36100
Correspondent Contact Alessandro Zorgati
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/27/2024
Decision Date 10/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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